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Questions and Answers
What agency may intervene in a matter or worker protection even if there are no specific regulations covering the situation?
What agency may intervene in a matter or worker protection even if there are no specific regulations covering the situation?
Occupational Safety and Health Administration
Regulations under the Clean Air Act are administered by which agency?
Regulations under the Clean Air Act are administered by which agency?
Environmental Protection Agency
Which agency imposes strict labeling requirements on manufacturers of disinfectants used by Central Service departments?
Which agency imposes strict labeling requirements on manufacturers of disinfectants used by Central Service departments?
Environmental Protection Agency
What do healthcare regulations and standards establish?
What do healthcare regulations and standards establish?
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Chemical indicators are classified as which type of medical devices?
Chemical indicators are classified as which type of medical devices?
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Heart valves and pacemakers are examples of what class of FDA medical devices?
Heart valves and pacemakers are examples of what class of FDA medical devices?
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Who is required to report suspected medical device-related deaths to the U.S. Food and Drug Administration?
Who is required to report suspected medical device-related deaths to the U.S. Food and Drug Administration?
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Standards and regulations help set levels of ________________________ in our departments.
Standards and regulations help set levels of ________________________ in our departments.
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Medical device reporting is regulated by which agency?
Medical device reporting is regulated by which agency?
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What does the Department of Transportation enforce regulations relating to?
What does the Department of Transportation enforce regulations relating to?
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Sometimes state or local regulations differ from federal regulations and when that happens, the most stringent regulations apply.
Sometimes state or local regulations differ from federal regulations and when that happens, the most stringent regulations apply.
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It is optional to allow the Occupational Safety and Health Administration's regulation for wearing personal protective equipment in the Central Service decontamination.
It is optional to allow the Occupational Safety and Health Administration's regulation for wearing personal protective equipment in the Central Service decontamination.
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Third-party reprocessors are regulated by the U.S. Food and Drug Administration.
Third-party reprocessors are regulated by the U.S. Food and Drug Administration.
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Recommendations regarding sterilization practices are provided by the Association for the Advancement of Medical Instrumentation.
Recommendations regarding sterilization practices are provided by the Association for the Advancement of Medical Instrumentation.
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The Occupational Safety and Health Administration is a voluntary association dedicated to infection control and prevention.
The Occupational Safety and Health Administration is a voluntary association dedicated to infection control and prevention.
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Failure to receive accreditation from The Joint Commission can result in the loss of Medicare and Medicaid payments.
Failure to receive accreditation from The Joint Commission can result in the loss of Medicare and Medicaid payments.
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The Society of Gastroenterology Nurses and Associates is a source for information about the proper processing of flexible endoscopes.
The Society of Gastroenterology Nurses and Associates is a source for information about the proper processing of flexible endoscopes.
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Class III medical devices are identified as high risk.
Class III medical devices are identified as high risk.
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Reuse of single-use medical devices is less regulated now than it was in the 1990s.
Reuse of single-use medical devices is less regulated now than it was in the 1990s.
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The U.S. Food and Drug Administration recalls may be either mandatory or voluntary.
The U.S. Food and Drug Administration recalls may be either mandatory or voluntary.
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Study Notes
Regulatory Agencies and Their Roles
- Occupational Safety and Health Administration (OSHA) intervenes in worker protection matters even without specific regulations.
- Environmental Protection Agency (EPA) administers Clean Air Act regulations and enforces strict labeling on disinfectants used in Central Service departments.
Healthcare Regulations and Standards
- Healthcare regulations establish minimal levels of quality and safety for medical practices.
- Standards and regulations are essential for maintaining quality and safety in healthcare departments.
Medical Device Classifications
- Chemical indicators classified as FDA Class II medical devices.
- Heart valves and pacemakers categorized under FDA Class III medical devices, indicating high risk.
Reporting and Compliance
- Device manufacturers and hospitals are mandated to report suspected medical device-related deaths to the U.S. Food and Drug Administration (FDA).
- Third-party reprocessors are regulated by the FDA, ensuring compliance with safety standards.
Accreditation and Impact on Services
- Accreditation from The Joint Commission is crucial, as failure to receive it can lead to loss of Medicare and Medicaid reimbursements.
- Recommendations for sterilization practices are provided by the Association for the Advancement of Medical Instrumentation.
Local vs. Federal Regulations
- When state or local regulations conflict with federal regulations, the most stringent rules apply to ensure higher safety standards.
Personal Protective Equipment (PPE) Regulations
- Compliance with OSHA regulations regarding personal protective equipment in Central Service decontamination is mandatory, not optional.
Medical Device Reporting and Recall
- Medical device reporting is strictly regulated by the FDA; recalls can be either mandatory or voluntary.
Reprocessing and Safety
- Reuse of single-use medical devices is currently more regulated than in the 1990s, responding to safety concerns and practices.
- The Society of Gastroenterology Nurses and Associates provides guidance on the proper processing of flexible endoscopes.
Risk Assessment
- FDA Class III medical devices are identified as high-risk items, requiring stringent regulatory oversight to ensure patient safety.
Studying That Suits You
Use AI to generate personalized quizzes and flashcards to suit your learning preferences.
Description
Test your knowledge with these flashcards from Chapter 5 of the IAHCSMM 8th Edition. Focus on key terms and definitions related to central service and safety regulations. Ideal for students and professionals preparing for certification or review in the field.
